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510(k) Data Aggregation

    K Number
    K161865
    Device Name
    iSage Rx (iSage Rx Basal Insulin Titration)
    Manufacturer
    iSag Rx, Inc.
    Date Cleared
    2017-03-07

    (243 days)

    Product Code
    NDC
    Regulation Number
    868.1890
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    iSag Rx, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    iSage Rx™ (iSage Rx Basal Insulin Titration) is software indicated for use by adult patients aged 21 and above who have type 2 diabetes and their healthcare providers to titrate basal insulin. iSage Rx is not intended to replace the care and management provided by a healthcare professional trained in the management of diabetes. iSage Rx should not be used by patients with type 2 diabetes who are also using prandial insulin or patients with type 1 diabetes, or patients using an insulin pump.

    Device Description

    iSage Rx™ (iSage Rx Basal Insulin Titration) is software

    AI/ML Overview

    This document does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the iSage Rx device, primarily focusing on the regulatory aspects of substantial equivalence, general controls, and indications for use. It does not include details on the specific performance study conducted to demonstrate the device's efficacy or safety, nor does it specify acceptance criteria for such a study.

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